Supplier Quality Engineer

Give hope. Give health. Make your mark in the fight against cancer.

At Accuray, we make a direct and powerful impact on the lives of cancer patients every day — helping them live longer, better lives. But our commitment to innovation offers a truly unique opportunity: the chance to change the fight against cancer — helping to develop, introduce and support new treatment delivery systems and software that will give new hope and new health to cancer patients and cancer survivors around the world.

Accuray develops, manufactures and sells radiotherapy systems for alternative cancer treatments. Our radiation therapy for cancer makes treatment shorter, safer, personalized and more effective, ultimately enabling patients to live longer, better lives.

Job Description

SUMMARY: 

The supplier quality engineer is a member of the quality assurance team who plans and performs activities related to the selection, monitoring, and control of purchased materials and suppliers.  They work cross-functionally with engineering, procurement, manufacturing, service, and other quality teams to support all phases of the product lifecycle from initial product development through customer support.

Successful candidates for this role must demonstrate a high degree of resourcefulness by delivering timely and effective results in a dynamic and fast-paced environment with a high degree of autonomy.

REPORTING TO/DEPARTMENT: 

Reports to the Director, Quality Assurance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Maintain the approved supplier list (ASL) for material and service suppliers.
• Evaluate and influence selection of new suppliers for quality, delivery, and cost.
• Plan, conduct, and document supplier audits and assist or lead audit program planning.
• Negotiate and ensure adherence to supplier quality agreements.
• Update supplier qualification records including surveys and certifications.
• Review and update supplier risk evaluations.
• Review engineering change orders (ECOs) and procurement specifications for supplier manufacturability.
• Setup supplier and part information in the enterprise resource planning (ERP) system.
• Request and review supplier part qualification information including first article inspection reports (FAIRs) and other production part approval (PPAP) information.
• Setup, review, and update incoming inspection plans.
• Investigate purchased material defects encountered during inspection, assembly, testing, installation, and servicing.
• Review and trend supplier defect data and issue supplier defect notices (SDNs).
• Issue, review, and follow-up on supplier corrective actions requests (SCARs).
• Prepare materials for and records of supplier review board (SRB) meetings.
• Update standard operating procedures (SOPs), work instructions (WIs), and job aids.

QUALIFICATIONS:

Preferred

• Experience working with complex, software-driven, electro-mechanical systems.
• Familiarity with state-of-the-art processes used to manufacture RF and X-ray generation/detection/imaging subsystems, printed circuit assemblies, high performance computers, cables/wire harnesses, and/or fabricated/machined components.
• Prior experience planning and reviewing purchased part qualification activities using PPAP or similar processes.
• Lead auditor certification with prior supplier auditing experience.
• Relevant quality certification(s) like ASQ CMQ/OE, ASQ CSQP, ASQ CQE, etc.

Required

• 3+ years’ experience working in a highly regulated manufacturing environment operating within an ISO 9001 or 13485, 21 CFR 820, or similar quality system.
• 1+ year experience directly managing quality performance of suppliers.
• Bachelor’s degree in one of the following (or similar) engineering disciplines: electrical, industrial, manufacturing, mechanical, quality.
• Fully proficient with instant messaging, video conferencing, general office applications, ERP, and quality system software like Zoom, Microsoft Office suite, SAP, and Master Control.
• High organized and driven performer with a demonstrated track record of achievement delivering improved products and services for customers and internal stakeholders with urgency.
• Strong ability to influence others within and outside the company using well developed verbal and written communication skills.
• Strong analytical, critical thinking, and problem-solving skills.
• Ability to consistently work on-site and travel between multiple Madison-area facilities.
• Ability to travel to local, domestic, and international suppliers